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New treatment option for Thoracic Aortic Aneurysm
Official title B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
ClinicalTrials.gov ID: NCT04747626
What this study is testing
- What it's testing
- A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- At least 18 years of age
- Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given...
- Expected life expectancy of greater than two years after repair
- Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the...
You likely can't join if
- Subject is unfit for open surgical repair involving circulatory arrest
- Subject is comatose or suffering from irreversible severe brain malperfusion
- Subject has known sensitivity to components of the devices
- Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
- Subject is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to...
- Subject has an uncorrectable bleeding anomaly
See the full eligibility criteria
- At least 18 years of age
- Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given written informed consent for the subject to participate in the study.
- Expected life expectancy of greater than two years after repair
- Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the following condition): Thoracic aortic aneurysm considered at increased...
- Subject is unfit for open surgical repair involving circulatory arrest
- Subject is comatose or suffering from irreversible severe brain malperfusion
- Subject has known sensitivity to components of the devices
- Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
- Subject is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of...
- Subject has an uncorrectable bleeding anomaly
- Subject has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- procedure
- Subject is pregnant
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.